St. Jude gets FDA warning for improper promotion of catheterby Brandon Glenn, MedCity News
St. Paul, Minn. — The U.S. Food and Drug Administration has sent a warning letter to St. Jude Medical Inc. that cites the device maker for improperly promoting a cardiac ablation catheter system.
St. Jude on its website promoted its Epicor cardiac ablation catheter system for use in treating atrial fibrillation, an irregular heartbeat that can result in stroke. However, the system has only received FDA approval to be used in ablation, or destruction, of diseased heart tissue during surgery.
St. Jude has received the go-ahead from the FDA to investigate the device's use in treating atrial fibrillation, but that's a far cry from government approval to sell and market the device.
In addition to the unapproved claims on St. Jude's website, the FDA found similar problems with marketing brochures and materials aimed at physicians.
The FDA gave St. Jude 15 days to provide written documentation of what it's doing to correct the problem.
The company told the Associated Press that it's "working diligently to address the points raised in the warning letter and to resolve the FDA's concerns."
The warning letter was dated April 23, but first posted to the FDA's website Tuesday.
In its most recent quarterly report, St. Jude cited an investigation by the U.S. Department of Justice into similar false marketing claims of the Epicor device. St. Jude said it received a letter from the DOJ regarding the matter in October 2008. The company said it's cooperating with the investigation.
St. Jude acquired Epicor Medical Inc. and its eponymous device in 2004 for $185 million.
Last year, Johnson & Johnson became the first company to receive FDA approval for treatment of atrial fibrillation via an ablation catheter system, called the Navistar Thermocool.